PMID- 11824947 OWN - NLM STAT- MEDLINE DCOM- 20020702 LR - 20151119 IS - 0315-162X (Print) IS - 0315-162X (Linking) VI - 29 IP - 1 DP - 2002 Jan TI - Successful short term treatment of severe undifferentiated spondyloarthropathy with the anti-tumor necrosis factor-alpha monoclonal antibody infliximab. PG - 118-22 AB - OBJECTIVE: Tumor necrosis factor-alpha (TNF-alpha) has been detected in sacroiliac joints of patients with spondyloarthropathies (SpA). Anti-TNF-a therapy has been efficacious in patients with active ankylosing spondylitis (AS) and psoriatic arthritis. Similar to these SpA subtypes, therapeutic options in undifferentiated SpA (uSpA) are also limited. We tested the efficacy of the monoclonal anti-TNF-alpha antibody infliximab in patients with active and severe uSpA in an open observation trial. METHODS: Six patients with uSpA were treated with 3 infusions of infliximab in a dosage of 3 (n = 3) or 5 mg/kg (n = 3) at Weeks 0, 2, and 6. The total observational period was 12 weeks. The Bath AS Disease Activity Index (BASDAI), the Functional Index (BASFI), pain on a visual analog scale, the Bath AS Metrology Index (BASMI), and quality of life (SF-36) were assessed before, during, and after therapy. RESULTS: Significant improvement at Day 1 after the first infusion lasting until Week 12 was reported by 5/6 patients. Improvement of > or = 50% in all activity, function, pain, and swollen joint scores was observed in the patients taking 5 mg/kg. The 3 mg/kg dose was less effective, resulting in > or = 15% improvement in outcome variables. Peripheral arthritis, enthesitis, and spinal symptoms improved equally. C-reactive protein dropped in 4 patients. Health related quality of life increased. No serious side effects or infections occurred. CONCLUSION: These observations suggest that anti-TNF-alpha therapy has significant short term efficacy in patients with severe uSpA. FAU - Brandt, Jan AU - Brandt J AD - Department of Gastroenterology and Rheumatology, Benjamin Franklin Hospital, Free University Berlin, Germany. FAU - Haibel, Hildrun AU - Haibel H FAU - Reddig, Jaqueline AU - Reddig J FAU - Sieper, Joachim AU - Sieper J FAU - Braun, Jurgen AU - Braun J LA - eng PT - Clinical Trial PT - Controlled Clinical Trial PT - Journal Article PL - Canada TA - J Rheumatol JT - The Journal of rheumatology JID - 7501984 RN - 0 (Antibodies, Monoclonal) RN - 0 (Antirheumatic Agents) RN - 0 (Tumor Necrosis Factor-alpha) RN - 9007-41-4 (C-Reactive Protein) RN - B72HH48FLU (Infliximab) SB - IM MH - Acute Disease MH - Adult MH - Antibodies, Monoclonal/*therapeutic use MH - Antirheumatic Agents/*therapeutic use MH - C-Reactive Protein/immunology/metabolism MH - Dose-Response Relationship, Drug MH - Edema/drug therapy/immunology/pathology MH - Female MH - Humans MH - Infliximab MH - Male MH - Middle Aged MH - Quality of Life/psychology MH - Recovery of Function/drug effects/immunology MH - Spondylarthropathies/*drug therapy/immunology/physiopathology MH - Treatment Outcome MH - Tumor Necrosis Factor-alpha/*antagonists & inhibitors/immunology/metabolism MH - Zygapophyseal Joint/*drug effects/immunology/pathology EDAT- 2002/02/05 10:00 MHDA- 2002/07/03 10:01 CRDT- 2002/02/05 10:00 PHST- 2002/02/05 10:00 [pubmed] PHST- 2002/07/03 10:01 [medline] PHST- 2002/02/05 10:00 [entrez] PST - ppublish SO - J Rheumatol. 2002 Jan;29(1):118-22.